Drug Facts

Drug Facts
SPL v5
SPL
SPL Set ID 812a093f-cf83-4f7a-927a-1b5695be7f90
Route
ORAL
Published
Effective Date 2025-05-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (1000 mg) Dextromethorphan (30 mg) Chlorpheniramine (4 mg)
Inactive Ingredients
Acesulfame Potassium Anhydrous Citric Acid Aspartame D&c Yellow No. 10 Fd&c Blue No. 1 Fd&c Red No. 40 Maltodextrin Silicon Dioxide Sodium Citrate, Unspecified Form Soybean Lecithin Sucrose Tribasic Calcium Phosphate

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-06-15
Description

Acetaminophen 1000 mg Dextromethorphan HBr 30 mg

Purpose

Pain reliever/Fever reducer Cough suppressant

Medication Information

Purpose

Pain reliever/Fever reducer Cough suppressant

Description

Acetaminophen 1000 mg Dextromethorphan HBr 30 mg

Uses
  • temporarily relieves these symptoms due to a common cold or flu:
    • headache
    • minor aches and pains
    • cough due to minor throat and bronchial irritation
    • minor sore throat pain
  • temporarily reduces fever
Purposes

Pain reliever/Fever reducer

Cough suppressant

Warnings

Liver warning:This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Allergy alert:Acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash
  • If a skin reaction occurs, stop use and seek medical help right away.

Sore throat warning:If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting consult a doctor promptly.

Directions
  • do not use more than directed
  • take every 6 hours, while symptoms persist. Do not take more than 3 packets in 24 hours unless directed by a doctor.
  • Age
  • Dose
  • adults and children 12 years of age and over
  • one packet
  • children under 12 years of age
  • do not use
  • dissolve contents of one packet into 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes.
  • if using a microwave, add contents of one packet to 8 oz. of cool water; stir briskly before and after heating. Do not overheat.
Do Not Use
  • in a child under 12 years of age
  • if you are allergic to acetaminophen
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Other Information
  • each packet contains:potassium 10 mg, sodium 20 mg
  • phenylketonurics:contains phenylalanine 19.6 mg per packet
  • store at a controlled room temperature at 20 - 25°C (68-77°F)
Inactive Ingredients

acesulfame potassium, anhydrous citric acid, aspartame, D&C yellow no. 10, FD&C blue no. 1, FD&C red no. 40, maltodextrin, natural and artificial flavors, silicon dioxide, sodium citrate, soy lecithin, sucrose, tribasic calcium phosphate

Additional Information

READ ALL WARNINGS AND DIRECTIONS ON CARTON BEFORE USE.

KEEP CARTON FOR REFERENCE. DO NOT DISCARD.

DO NOT TAKE THE DAYTIME AND NIGHTTIME PRODUCTS AT THE SAME TIME.

DO NOT TAKE MORE THAN 3 DOSES IN TOTAL IN ANY 24 HOUR PERIOD.

DO NOT TAKE A DOSE OF THE NIGHTTIME PRODUCT SOONER THAN 6 HOURS AFTER THE LAST DOSE OF THE DAYTIME PRODUCT UNLESS DIRECTED BY YOUR DOCTOR.

DO NOT TAKE BOTH PRODUCTS AT THE SAME TIME

OR TAKE MORE THAN 3 DOSES IN TOTAL IN ANY 24 HOUR PERIOD.

PARENTS:Learn about teen medicine abuse

www.StopMedicineAbuse.org

*Maximum Strength per 6 hour dose

TAMPER-EVIDENT INNER UNIT. DO NOT USE IF SEALED THERAFLU PACKET IS TORN OR BROKEN.

1-855-297-3031

Distributed by: Haleon, Warren, NJ 07059

Trademarks are owned by or licensed to the Haleon group of companies.

©2025 Haleon group of companies or its licensor.

Questions Or Comments?

1-855-297-3031

Principal Display Panel

MULTI-SYMPTOM FLU RELIEF

HALEON

THERAFLU

FLU RELIEF MAX STRENGTH*

6 x DAYTIME

AcetaminophenPain Reliever/Fever Reducer

Dextromethorphan HBrCough Suppressant

6 x NIGHTTIME

AcetaminophenPain Reliever/Fever Reducer

Chlorpheniramine MaleateAntihistamine

Dextromethorphan HBrCough Suppressant

Hot liquid therapy that relieves:

/ Fever

/ Body ache

/ Headache

/ Sore throat pain

/ Cough

/ Runny nose (Nighttime only)

6 DAYTIME PACKETS

6 NIGHTTIME PACKETS

12 TOTAL PACKETS

Honey Lemon Flavor

USE ONLY AS DIRECTED

62000000214400 Front Carton

When Using This Product
  • avoid alcoholic drinks
  • marked drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children
Stop Use and Ask A Doctor If
  • pain or cough gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • cough comes back or occurs with rash or headache that lasts
  • These could be signs of a serious condition.
If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Active Ingredients (in Each Packet)

Acetaminophen 1000 mg

Dextromethorphan HBr 30 mg

Ask A Doctor Before Use If You Have
  • liver disease
  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
Ask A Doctor Or Pharmacist Before Use If You Are
  • taking the blood thinning drug warfarin

Structured Label Content

Uses
  • temporarily relieves these symptoms due to a common cold or flu:
    • headache
    • minor aches and pains
    • cough due to minor throat and bronchial irritation
    • minor sore throat pain
  • temporarily reduces fever
Purposes

Pain reliever/Fever reducer

Cough suppressant

Warnings

Liver warning:This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Allergy alert:Acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash
  • If a skin reaction occurs, stop use and seek medical help right away.

Sore throat warning:If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting consult a doctor promptly.

Directions
  • do not use more than directed
  • take every 6 hours, while symptoms persist. Do not take more than 3 packets in 24 hours unless directed by a doctor.
  • Age
  • Dose
  • adults and children 12 years of age and over
  • one packet
  • children under 12 years of age
  • do not use
  • dissolve contents of one packet into 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes.
  • if using a microwave, add contents of one packet to 8 oz. of cool water; stir briskly before and after heating. Do not overheat.
Do Not Use (Do not use)
  • in a child under 12 years of age
  • if you are allergic to acetaminophen
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Other Information (Other information)
  • each packet contains:potassium 10 mg, sodium 20 mg
  • phenylketonurics:contains phenylalanine 19.6 mg per packet
  • store at a controlled room temperature at 20 - 25°C (68-77°F)
Inactive Ingredients (Inactive ingredients)

acesulfame potassium, anhydrous citric acid, aspartame, D&C yellow no. 10, FD&C blue no. 1, FD&C red no. 40, maltodextrin, natural and artificial flavors, silicon dioxide, sodium citrate, soy lecithin, sucrose, tribasic calcium phosphate

Additional Information

READ ALL WARNINGS AND DIRECTIONS ON CARTON BEFORE USE.

KEEP CARTON FOR REFERENCE. DO NOT DISCARD.

DO NOT TAKE THE DAYTIME AND NIGHTTIME PRODUCTS AT THE SAME TIME.

DO NOT TAKE MORE THAN 3 DOSES IN TOTAL IN ANY 24 HOUR PERIOD.

DO NOT TAKE A DOSE OF THE NIGHTTIME PRODUCT SOONER THAN 6 HOURS AFTER THE LAST DOSE OF THE DAYTIME PRODUCT UNLESS DIRECTED BY YOUR DOCTOR.

DO NOT TAKE BOTH PRODUCTS AT THE SAME TIME

OR TAKE MORE THAN 3 DOSES IN TOTAL IN ANY 24 HOUR PERIOD.

PARENTS:Learn about teen medicine abuse

www.StopMedicineAbuse.org

*Maximum Strength per 6 hour dose

TAMPER-EVIDENT INNER UNIT. DO NOT USE IF SEALED THERAFLU PACKET IS TORN OR BROKEN.

1-855-297-3031

Distributed by: Haleon, Warren, NJ 07059

Trademarks are owned by or licensed to the Haleon group of companies.

©2025 Haleon group of companies or its licensor.

Questions Or Comments? (Questions or comments?)

1-855-297-3031

Principal Display Panel

MULTI-SYMPTOM FLU RELIEF

HALEON

THERAFLU

FLU RELIEF MAX STRENGTH*

6 x DAYTIME

AcetaminophenPain Reliever/Fever Reducer

Dextromethorphan HBrCough Suppressant

6 x NIGHTTIME

AcetaminophenPain Reliever/Fever Reducer

Chlorpheniramine MaleateAntihistamine

Dextromethorphan HBrCough Suppressant

Hot liquid therapy that relieves:

/ Fever

/ Body ache

/ Headache

/ Sore throat pain

/ Cough

/ Runny nose (Nighttime only)

6 DAYTIME PACKETS

6 NIGHTTIME PACKETS

12 TOTAL PACKETS

Honey Lemon Flavor

USE ONLY AS DIRECTED

62000000214400 Front Carton

When Using This Product (When using this product)
  • avoid alcoholic drinks
  • marked drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • pain or cough gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • cough comes back or occurs with rash or headache that lasts
  • These could be signs of a serious condition.
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Active Ingredients (in Each Packet) (Active ingredients (in each packet))

Acetaminophen 1000 mg

Dextromethorphan HBr 30 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • liver disease
  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)
  • taking the blood thinning drug warfarin

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:09.310465 · Updated: 2026-03-14T23:08:46.104923